Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes
Public ClinicalTrials.gov record NCT01646320. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Therapy With Dapagliflozin Added to Saxagliptin in Combination With Metformin Compared to Therapy With Placebo Added to Saxagliptin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Saxagliptin
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.
Study identification
- NCT ID
- NCT01646320
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 320 participants
Conditions and interventions
Conditions
Interventions
- Dapagliflozin Drug
- Placebo matching with Dapagliflozin Drug
- Saxagliptin Drug
- Metformin immediate release (IR) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2012 (Type not available)
- Primary completion
- Aug 2014 (Actual)
- Completion
- Feb 2015 (Actual)
- Last update posted
- Jun 22, 2016
2012 – 2015
United States locations
- U.S. sites
- 26
- U.S. states
- 14
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Of Alabama At Birmingham | Birmingham | Alabama | 35294 | — |
| Clinical Research Advantage Inc/Desert Clinical Research Llc | Mesa | Arizona | 85213 | — |
| Clinical Research Advantage, Inc. | Phoenix | Arizona | 85018 | — |
| Elite Clinical Studies, Llc | Phoenix | Arizona | 85018 | — |
| Arkansas Clinical Research | Little Rock | Arkansas | 72205 | — |
| Torrance Clinical Research Institute Inc. | Lomita | California | 90717 | — |
| Randall G. Shue, Do, Inc. | Los Angeles | California | 90023 | — |
| National Research Institute | Los Angeles | California | 90057 | — |
| Diabetes Medical Center Of California | Northridge | California | 91325 | — |
| Cassidy Medical Group/Clinical Research Advantage | Vista | California | 92083 | — |
| Palm Springs Research Institute | Hialeah | Florida | 33012 | — |
| Fpa Clinical Research | Kissimmee | Florida | 34741 | — |
| International Research Associates, Llc | Miami | Florida | 33183 | — |
| Omega Research Consultants, Llc | Orlando | Florida | 32804 | — |
| Compass Research East, Llc | Oviedo | Florida | 32765 | — |
| Palm Harbor Medical Associates | Palm Harbor | Florida | 34684 | — |
| Cedar Crosse Research Center | Chicago | Illinois | 60607 | — |
| Clinical Research Advantage | Evansville | Indiana | 47714 | — |
| Associated Internal Medicine Specialists | Battle Creek | Michigan | 49015 | — |
| Jackson Clinic | Rolling Fork | Mississippi | 39159 | — |
| Premier Research | Trenton | New Jersey | 08611 | — |
| Metrolina Internal Medicine | Charlotte | North Carolina | 28204 | — |
| Sterling Research Grp, Ltd. | Cincinnati | Ohio | 45246 | — |
| Endocrine Associates | Houston | Texas | 77004 | — |
| Sam Clinical Research Center | San Antonio | Texas | 78229 | — |
| Tidewater Integrated Medical Research | Virginia Beach | Virginia | 23454 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 40 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01646320, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 22, 2016 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01646320 live on ClinicalTrials.gov.